2024-08-31 2024-08-31 , online online, 1,290 € zzgl. MwSt. Gabriele Eibenstein M.A. https://forum-institut.de/seminar/25042610-marketing-authorisation-procedures-in-the-eu/referenten/25/25_04/25042610-course-marketing-authorisation-procedures-in-the-eu_eibenstein-ma-gabriele.jpg Marketing Authorisation Procedures in the EU

This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.

Topics
  • EU regulatory framework and legal basis
  • Mutual recognition and decentralised procedures (MRP and DCP)
  • Centralised procedure (CP)
  • Specifics for generic drug approvals


Who should attend
This seminar is intended for professionals involved in the drug approval process needing in-depth knowledge of European approval procedures. It is specifically tailored for beginners and career changers.
Aims and objectives
This seminar provides a comprehensive understanding of EU drug marketing authorisation procedures.

Participants will explore the regulatory framework, various application types, and detailed application procedures, gaining essential insights into navigating EU drug approval complexities.
Your benefit

  • In-depth knowledge of EU regulatory framework and marketing authorisation procedures
  • Insights into the roles and functions of relevant authorities and committees
  • Strategies for mutual recognition and decentralised procedures
  • Detailed understanding of the centralised procedure and scientific advice process
  • Specific information on data exclusivity, innovation protection and requirements for generics

Course: Marketing Authorisation Procedures in the EU

Marketing Authorisation Procedures in the EU

Benefits
  • Comprehensive EU regulatory insights
  • Detailed coverage of MRP, DCP and CP
  • Expert-led practical guidance
  • Certified to ISO 9001 and ISO 21001 standard

Webcode 25042610

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Termin

09/04/2025

09/04/2025

Zeitraum

from 09:00 -17:00
You may dial-in 30 minutes before

from 09:00 -17:00
You may dial-in 30 minutes before
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Dr. Rebekka Bitsch
Conference Manager

+49 6221 500-565
r.bitsch@forum-institut.de

Details

This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.

Topics

  • EU regulatory framework and legal basis
  • Mutual recognition and decentralised procedures (MRP and DCP)
  • Centralised procedure (CP)
  • Specifics for generic drug approvals


Who should attend
This seminar is intended for professionals involved in the drug approval process needing in-depth knowledge of European approval procedures. It is specifically tailored for beginners and career changers.

Aims and objectives

This seminar provides a comprehensive understanding of EU drug marketing authorisation procedures.

Participants will explore the regulatory framework, various application types, and detailed application procedures, gaining essential insights into navigating EU drug approval complexities.

Your benefit

  • In-depth knowledge of EU regulatory framework and marketing authorisation procedures
  • Insights into the roles and functions of relevant authorities and committees
  • Strategies for mutual recognition and decentralised procedures
  • Detailed understanding of the centralised procedure and scientific advice process
  • Specific information on data exclusivity, innovation protection and requirements for generics

Detailed programme

from 09:00 -17:00
You may dial-in 30 minutes before

Welcoming and introduction round


Dr Christian M. Moers

Basic principles and terminology
  • The regulatory framework: regulations, directives and guidelines
  • Involved authorities
  • The available marketing authorisation procedures: centralised, decentralised and national
  • Role of the coordination group (CMDh)

Coffee break


Dr Christian M. Moers

Legal basis for marketing authorisation procedures in Europe
  • Full application, bibliographic application, mixed application, and informed consent
  • Generic application, hybrid application and biosimilars
  • Registration

Lunch break


Gabriele Eibenstein, M.A.

Mutual recognition and decentralised procedures
  • Common principles
  • Submission strategy
  • Deadlines and clock stops

Gabriele Eibenstein, M.A.

Centralised procedure
  • Scope and mandatory products
  • Role of the EMA and committees, e.g. CHMP
  • The procedure in detail
  • Scientific advice
  • Challenges for innovative products

Coffee break


Dr Christian M. Moers

Specifics for generics
  • Data exclusivity and innovation protection
  • European reference product

Questions and answers


End of the seminar


More Information

E-Learning: Introduction to EU Marketing Authorisation

Do you lack basic marketing authorisation expertise? Then, we would recommend the e-Learning 'Introduction to EU Marketing Authorisation' e-learning.
This will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.

Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.

Please register for the seminar "Marketing Authorisation Procedures in the EU" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning (you will be billed €290 + local VAT rather than €390 + local VAT).

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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